Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2025-12-24 @ 3:38 PM
NCT ID:
NCT02005692
Eligibility Criteria:
Inclusion Criteria:
* Adult male or female 18 to 110 years of age;
* Inpatient currently on the unit and expected to remain for at least 12 hours;
* Able and willing to comply with the study procedures;
* Subject (or his/her agent) is able to read, understand, and provide Informed Consent in the English language.
Exclusion Criteria:
* Subject is a female subject under the age of 60 who is pregnant, planning on becoming pregnant, or is currently breastfeeding.
1. Any woman under the age of 60, must have a negative urine pregnancy test prior to being enrolled in the study; OR
2. Be postmenopausal for at least 2 years, OR
3. have had a bilateral tubal ligations, OR
4. have had a bilateral oophorectomy, OR
5. have had a hysterectomy.
* Subjects with a known tape allergy or sensitivity to EKG leads or similar types of adhesives used in common medical products.
* Subjects who cannot have the patient sensor applied on the surface of the patient's anterior torso.
* Subjects who have a pacemaker or implantable cardiovascular-defibrillator (ICD).
* Subjects with dementia, Alzheimer's disease or other mental disabilities and incapacitation that would prevent the subject from providing written informed consent. If the subject is unable to provide informed consent due to mental incapacity, then the subject's Durable Power of Attorney may provide informed consent and sign the informed consent on behalf of the subject.
* Subjects who refuse to have an area of hair on their chest be clipped or shaved, if needed for patient sensor adhesion.
* Subjects, who in the opinion of the Principal Investigator, are at increased risk by participating in the clinical study.
* Subjects who have participated in another clinical study within the past 30 days or are currently participating in another clinical study at the time of screening.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02005692
Study Brief:
Protocol Section:
NCT02005692